ASTM F2027-2016 Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products《组织工程医疗产品原料或初始材料的表征和试验的标准指南》.pdf
《ASTM F2027-2016 Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products《组织工程医疗产品原料或初始材料的表征和试验的标准指南》.pdf》由会员分享,可在线阅读,更多相关《ASTM F2027-2016 Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products《组织工程医疗产品原料或初始材料的表征和试验的标准指南》.pdf(8页珍藏版)》请在麦多课文档分享上搜索。
1、Designation: F2027 08F2027 16Standard Guide forCharacterization and Testing of Raw or StartingBiomaterialsMaterials for Tissue-Engineered MedicalProducts1This standard is issued under the fixed designation F2027; the number immediately following the designation indicates the year oforiginal adoption
2、 or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 This document provides guidance on writing a materials specification for raw
3、 or starting biomaterialsmaterials intended foruse in tissue engineering scaffolds for growth, support, or delivery of cells and/or biomolecules. This guide does not apply tobiomaterialsmaterials that are already in a scaffold form or are finished tissue-engineered medical products.1.2 The purpose o
4、f this guide is to provide a compendium of relevant existing standards and test methods for biomaterials-materials already commonly used within medical products and to provide characterization guidance for interim use of rawbiomaterialsmaterials for which a standard does not exist.1.3 This guide cov
5、ers specifications and characterizations of all the major classes of materials including polymers, ceramics,metals, composites, and natural tissues of human, animal, or plant origin. This guide does not apply to pharmaceuticals.1.4 This guide is focused on specification of chemical, physical, and me
6、chanical properties of the raw or starting material. Itdoes not include safety and biocompatibility requirements since safety and biocompatibility testing is typically done on materialsfabricated into a final form to include all possible effects of fabrication and sterilization techniques.1.5 Compli
7、ance with materials specifications developed in accordance with this standard may not necessarily result in a materialsuitable for its intended purpose. Additional testing specific to the intendintended use may be required.2. Referenced Documents2.1 ASTM Standards:2D1763 Specification for Epoxy Resi
8、nsD1898 Practice for Sampling of Plastics (Withdrawn 1998)3E1298 Guide for Determination of Purity, Impurities, and Contaminants in Biological Drug Products (Withdrawn 2014)3F67 Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNSR50700)F75
9、 Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNSR30075)F90 Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applications (UNSR30605)F136 Specification for Wrought Titanium-6Aluminum-4Vanadium ELI
10、(Extra Low Interstitial) Alloy for Surgical ImplantApplications (UNS R56401)F138 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants(UNS S31673)F139 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Sheet and Strip
11、for Surgical Implants(UNS S31673)F451 Specification for Acrylic Bone Cement1 This guide is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee F04.42on Biomaterials and Biomolecules for TEMPs.Current edition appr
12、oved May 1, 2008Oct. 1, 2016. Published June 2008December 2016. Originally approved in 2000. Last previous edition approved in 20002008 asF2027 00F2027 08.1. DOI: 10.1520/F2027-08.10.1520/F2027-16.2 For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at
13、 serviceastm.org. For Annual Book of ASTM Standardsvolume information, refer to the standardsstandards Document Summary page on the ASTM website.3 The last approved version of this historical standard is referenced on www.astm.org.This document is not an ASTM standard and is intended only to provide
14、 the user of an ASTM standard an indication of what changes have been made to the previous version. Becauseit may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current versionof the sta
15、ndard as published by ASTM is to be considered the official document.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States1F560 Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400)F562 Specificatio
16、n for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications(UNS R30035)F563 Specification for Wrought Cobalt-20Nickel-20Chromium-3.5Molybdenum-3.5Tungsten-5Iron Alloy for Surgical ImplantApplications (UNS R30563) (Withdrawn 2005)3F602 Criteria for Implantable Ther
17、moset Epoxy PlasticsF603 Specification for High-Purity Dense Aluminum Oxide for Medical ApplicationF604 Specification for Silicone Elastomers Used in Medical Applications (Withdrawn 2001)3F619 Practice for Extraction of Medical PlasticsF624 Guide for Evaluation of Thermoplastic Polyurethane Solids a
18、nd Solutions for Biomedical ApplicationsF639 Specification for Polyethylene Plastics for Medical ApplicationsF641 Specification for Implantable Epoxy Electronic EncapsulantsF648 Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical ImplantsF665 Classifica
19、tion for Vinyl Chloride Plastics Used in Biomedical ApplicationF702 Specification for Polysulfone Resin for Medical ApplicationsF755 Specification for Selection of Porous Polyethylene for Use in Surgical ImplantsF755 Specification for Selection of Porous Polyethylene for Use in Surgical ImplantsF997
20、 Specification for Polycarbonate Resin for Medical ApplicationsF1088 Specification for Beta-Tricalcium Phosphate for Surgical ImplantationF1185 Specification for Composition of Hydroxylapatite for Surgical ImplantsF1251 Terminology Relating to Polymeric Biomaterials in Medical and Surgical Devices (
21、Withdrawn 2012)3F1377 Specification for Cobalt-28Chromium-6Molybdenum Powder for Coating of Orthopedic Implants (UNS R30075)F1472 Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400)F1537 Specification for Wrought Cobalt-28Chromium-6Molybdenum A
22、lloys for Surgical Implants (UNS R31537, UNSR31538, and UNS R31539)F1538 Specification for Glass and Glass Ceramic Biomaterials for ImplantationF1579 Specification for Polyaryletherketone (PAEK) Polymers for Surgical Implant Applications (Withdrawn 2011)3F1581 Specification for Composition of Anorga
23、nic Bone for Surgical ImplantsF1634 Practice forIn-Vitro Environmental Conditioning of Polymer Matrix Composite Materials and Implant DevicesF1635 Test Method forin vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms forSurgical ImplantsF1713 Specification for
24、Wrought Titanium-13Niobium-13Zirconium Alloy for Surgical Implant Applications (UNS R58130)F1855 Specification for Polyoxymethylene (Acetal) for Medical ApplicationsF1873 Specification for High-Purity Dense Yttria Tetragonal Zirconium Oxide Polycrystal (Y-TZP) for Surgical ImplantApplications (Withd
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